The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
|Articles|September 1, 2010
- Pharmaceutical Technology-09-02-2010
- Volume 34
- Issue 9
Pharmaceutical Technology, September 2010 Issue (PDF)
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Articles in this issue
about 16 years ago
In the Spotlight Editor's Picksabout 16 years ago
FDA Struggles with Risk Management and Drug Safetyabout 16 years ago
Q&A with Diteba's Theo Kapanadzeabout 16 years ago
Strategic Approaches to Process Optimization and Scale-upabout 16 years ago
Above and Beyondabout 16 years ago
Report from Brazil September 2010about 16 years ago
Congress Attempts to Fix a System that Isn't Brokenabout 16 years ago
Technical Forum: Small-Molecule Synthesisabout 16 years ago
No More Exceptionsabout 16 years ago
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Subathra Ramamoorthy, Veranova, on when to escalate to structural elucidation and pair orthogonal techniques when characterizing an impurity.
Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.
The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
Manish Baviskar, Hubot CDMO, explains which AI skills validation engineers need first and why AI model updates must go through GMP change control.
Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF, talks about spray drying for drying amorphous solid dispersions and Raman spectroscopy’s role as a quantitative analytical tool.
Aleksandra Zuraw, senior veterinary pathologist at Charles River, discusses how chain of custody, good laboratory practice, quality control, and validation are applied to digital pathology data used in drug development.
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